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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K982280
Device Name CRYOPRO MAXI AND CRYOPRO MINI
Applicant
Cortex Technology Aps
1050 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact MARSHA WERTZBERGER
Correspondent
Cortex Technology Aps
1050 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact MARSHA WERTZBERGER
Regulation Number878.4350
Classification Product Code
GEH  
Date Received06/30/1998
Decision Date 11/25/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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